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Table 3 Study description, recruitment outcomes and three derived recruitment performance metrics for 16 clinical trials

From: Early experience with an opt-in research register - Scottish Health Research Register (SHARE): a multi-method evaluation of participant recruitment performance

Study Name Region(s) Involved Study Inclusion & Exclusion Criteria No. Requested by researchers No. Identified in EHRs No. Provided by SHARE to Research Team No. Recruited Percentage Identified and Recruited Percentage Provided and Recruited Percentage Fulfilled
A East Inclusion:
• Age: 18–75
• HFa
• Diabetes
• On Diuretic
Exclusion:
• On Insulin therapy
20 68 41 11 16.2 26.8 55.0
B Southeast Inclusion:
• Female
• Age: 18–50
• Complaint of HMBb
• Prescription for tranexamic acid or mefenamic acid
Exclusion:
• Cancer
• Severe Coagulation disorder
• Diabetes
• Hysterectomy
20 402 28 6 1.5 21.4 30.0
C All Inclusion:
• Age:> 18
• Experienced acute coronary syndrome in the previous six months
Exclusion:
• Currently in hospital for any reason
• Haven’t experienced acute coronary syndrome in the previous two weeks
177 NAy 33 16 /z 48.5 9.0
D East/West Inclusion:
• Age:> 18
• CKDc 3b or 4
Exclusion:
• Atrial fibrillation or flutter
• On warfarin
• Unable to give consent
• Taking Vitamin K
• Known contraindication to Vitamin K
• Intolerance to soya product
• Pregnant or capable of child-bearing
• Currently in another trial or within 30 days of completing another trial
165 237 35 7 3.0 20.0 4.2
E Southeast Inclusion:
• Age: 40–90
• Healthy
Exclusion:
• Diseases of eye and adnexa
• Inflammatory diseases of the central nervous system
• Systemic atrophies primarily affecting the central nervous system
• Extrapyramidal and movement disorders
• Other degenerative diseases of the nervous system
• Demyelinating diseases of the central nervous system
• Vascular syndromes of brain in cerebrovascular diseases
• Cerebral palsy and other paralytic syndromes
• Stroke, not specified as haemorrhage or infarction
150 809 150 79 9.8 52.7 52.7
F East Inclusion:
• LILRB5 rs12975366 genotype of either T/T or C/C
• Males aged 61–69 years or Females aged 40–69
• Not on statin
Exclusion:
• More than 3 prescriptions in last 12 months
40 136 33 17 12.5 51.5 42.5
G East Inclusion:
• Age:18–80
• White European
• Able to complete the symptom severity score and Bristol stool chart independently
• eGFRd > 60
Exclusion:
• Diabetes
• Involvement in CTIMPe within 30 days
• Pregnancy or planning to conceive
• Metformin history
• Gastrointestinal pathology
• Daily treatment with PPIf, anti-spasmodic, or anti-motility drugs or OCT1g inhibiting drugs
40 254 8 8 3.1 100.0 20.0
H Southeast Exclusion:
• Age:18–64 (inclusion)
• have a primary DSM-5h diagnosis of MDDi
• Not responding to at least 1 antidepressant currently taken
• be able to complete study questionnaires
Exclusion:
• Axis I psychiatric condition
• Onset of depression after 55 years of age
• Organic brain disease or demented
• Mental retardation
• Malignancy within the 5 years
• HIV
• Infection of hepatitis B virus
• Congestive heart failure
• Demyelinating diseases
• Gastrointestinal perforation
5 88 15 5 5.7 33.3 100.0
I Southeast Exclusion:
• Age: ≥18 years old
• men or post-menopausal women (women with no periods for at least 12 months or having a surgical menopause)
• Hypertension
Exclusion:
• Ischaemic heart disease
• Cardiac failure
• Cerebrovascular disease
• Liver impairment disease
• CKD stage 3–5
• Overdose or suicidal ideation
• Weight less than 55 kg
• Chronic pain requiring treatment
• with a known allergy to paracetamol
• concomitant use of NSAIDs, oral anticoagulants or corticosteroids
20 521 36 7 1.3 19.4 35.0
J North Inclusion:
• Males aged 18 or over
• Females, postmenopausal (least 2 years without menstruation)
• BMIj:19–35
• Healthy, free of long-term medication
Exclusion:
• Age: < 18
• Females, pre- or peri-menopausal (less than 2 years since last period)
• Smoking
• Drug abuse
• Acohol > 20 units/week
• Extreme diets or supplementation
• Physical or mental health problems
• Long-term medication
36 372 11 4 1.1 36.4 11.1
K East Inclusion:
• Age: 18–75
• NAFLDk or NASHl or Hepatic fibrosis
Exclusion:
• Any other liver condition
• Type 1 Diabetes
• BMI < 25 or > 45
• Previous Bariatric surgery
• History of proliferative retinopathy
• History of pancreatitis
• Any malignancy (except basal and squamous cell skin cancers) within the past 5 years
• eGFR < 30 ml/min/1.73 m2
• On Vitamin E or pioglitazone within 90 days
• On corticosteroids, methotrexate or tamoxifen or valproic acid or amiodarone, tetracycline within 28 days
• HbA1cm > 9%
• On GLP-1n RAso or SGLT-2p inhibitors within 90 days
3 87 9 1 1.1 11.1 33.3
L East Inclusion:
• Age: 18–80
• Type 2 diabetes
• HF
• LVSDq
• On Furosemide or bumetanide or torasemide
Exclusion:
• Age: < 18 or > 80
• Type 1 Diabetes (E10)
• Chronic Liver Disease
• Receiving dialysis
• Malignancy (receiving active treatment)
• Past or current treatment with SGLT2 inhibitor
• On thiazide diuretics
26 41 13 2 4.9 15.4 7.7
M Southeast Inclusion:
• 65 years old or older
• Residents of Edinburgh or surrounding areas (including Lothians)
Exclusion:
• Have a history of dementia
• Stroke
• Other neurological disorders
• Traumatic brain injury
• Major psychiatric disorders
300 1000 132 69 6.9 52.3 23.0
N East Inclusion:
• Age 40 and 80
• Age of diabetes diagnosis 35
• T2DMr/NIDDMs
• Metformin monotherapy
• HbA1c 8% (64 mmol/mmol)
• eGFR 50 ml/min-1
• ALTt 2.5*ULNu
Exclusion:
• Type 1 Diabetes Mellitus
• Anaemia (Haemoglobin < 12.0 g/dL for women, < 13.0 g/dL for men)
• Pregnancy, lactation or a female planning to conceive within the study period
• Established pancreatic disease
• Participating in clinical phase of another interventional trial/study or have done so within the last 30 days
20 169 22 7 4.1 31.8 35.0
O Southeast Inclusion:
• Males and females aged 18–40 years (inclusive at selection)
• Body mass index between 18.5-25 kg/m2 (lean group) or 30–55 kg/m2 (obese group)
• No acute or chronic medical conditions
Exclusion:
• Major psychiatric illness
• Recurrent depression/ cyclothymic disorder
• Diabetes
• Anti-diabetic drugs
• Anti-depressants and mood altering drugs
• Beta-blockers
• Anticoagulants and antiplatelets
• Glucocorticoids
18 233 32 7 3.0 21.9 38.9
P West Inclusion:
• Male or female, between and including 40–85 years of age
• A confirmed physician diagnosis of COPDv
• Current or ex-smoker with ≥10 pack years of smoking history.
• Post bronchodilator FEV1w/FVCx ratio < 0.7
• Post bronchodilator FEV1 ≥ 40% of the predicted value.
• To have had 1 or more COPD exacerbations in the last 12 months requiring intervention with oral corticosteroids and/or antibiotics such as Penicillins, Macrolides, Tetracyclines, Quinolones, Corticosteroids
• Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. long acting? 2 agonist [LABA], long acting muscarinic antagonist [LAMA]) with or without an inhaled corticosteroid maintenance therapy for their COPD such as Broncodilators, Corticosteroids (for more than 6 months)
Exclusion:
• Active interstitial lung disease
• Past history of lung cancer
• Significant bronchiectasis
• Cystic fibrosis
• Alpha-1 antitrypsin deficiency
• History of significant chronic asthma
• Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy
• Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina
• Myocardial infarction) within 6 months
• Stroke within the preceding 6 months
5 496 18 2 0.4 11.1 40.0
Median (Interquartile) 20 (19–40) 235 (100–395) 28 (14–34) 7 (5–10) 3.1 (1.4–5.5) 26.8 (19.7–42.5) 33.3 (15.6–39.5)
  1. aHeart Failure
  2. bHeavy Menstrual Bleeding
  3. cChronic Kidney Disease
  4. destimated Glomerular Filtration Rate
  5. eClinical Trial of Investigational Medicinal Product
  6. fProton-pump inhibitor
  7. gOrganic cation transporter 1
  8. hDSM-5: The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
  9. iMajor Depressive Depression
  10. jBody Mass Index
  11. kNon-Alcoholic Fatty Liver Disease
  12. lNonalcoholic Steatohepatitis
  13. mHemoglobin A1c
  14. nGlucagon-like peptide-1
  15. oreceptor agonists
  16. pSodium/Glucose Cotransporter 2
  17. qLeft Ventricular Systolic Dysfunction
  18. rType 2 Diabetes Mellitus
  19. sNon-Insulin-Dependent Diabetes Mellitus
  20. tAlanine Transaminase
  21. uUpper Limits of Normal
  22. vChronic Obstructive Pulmonary Disease
  23. wExpiratory volume measured during the first second of the forced breath
  24. xForced Vital Capacity
  25. ymissing data
  26. zcannot be calculated due to missing data